Leaflet: information for the user

Bisoprolol/Hydrochlorothiazide Teva 10 mg/25 mg film-coated tablets EFG

bisoprololhemifumarate/hydrochlorothiazide

Read this leaflet carefully before you start to take this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• Ifyou experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

This medication includes a selective beta receptor blocker (bisoprolol) and a thiazide diuretic (a medication to eliminate water from the body) (hydrochlorothiazide).

It is used to treat high blood pressure (essential hypertension) in adult patients whose blood pressure is not sufficiently controlled with bisoprolol or hydrochlorothiazide alone.

Do not take Bisoprolol/Hidroclorotiazida Teva

• If you are allergic to bisoprolol or hidroclorotiazida or any other component of this medication (listed in section 6).
• If you have acute heart failure or worsening (decompensation) of existing heart failure that requires treatment with intravenous substances to strengthen heart action.
• If you have heart failure caused by alterations in heart function (cardiogenic shock).
• If you have significant alterations in heart rhythm (second and third degree AV block without pacemaker, sick sinus syndrome, sinoatrial block).
• If you have a very slow heart rate (less than 60 beats per minute) before starting treatment.
• If you have a tendency to severe asthma.
• If you have severe circulatory problems (which may cause numbness in hands and feet or make them pale or blue) (Raynaud's syndrome).
• If you have a tumor of the adrenal gland (pheochromocytoma) and are not being treated.
• If you have excessive acid in the blood (metabolic acidosis).
• If you have severe kidney function disorder (renal insufficiency) with little or no urine production (creatinine clearance less than or equal to 30 ml/minute or serum creatinine above 1.8 mg/100 ml).
• If you have acute inflammation of the kidneys (glomerulonephritis).
• If you have loss of consciousness caused by severe liver diseases (hepatic coma/precoma).
• If you have potassium deficiency (hypokalemia) that does not respond to treatment.
• If you have severe sodium deficiency (hyponatremia).
• If you have high serum calcium levels (hypercalcemia).
• If you have gout.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bisoprolol/Hidroclorotiazida Teva:

• If you have heart failure (chronic heart failure treatment should start with a gradual increase only of bisoprolol).
• If you have asthma or chronic obstructive pulmonary disease.
• If you are to receive general anesthesia (e.g. for surgery).
• If you have diabetes mellitus with strong fluctuations in blood glucose levels; symptoms of very low blood glucose (hypoglycemia) may be masked.
• If you are on a very strict diet.
• During desensitization treatment.
• If you have minor heart rhythm disorders (first degree AV block).
• If you have alterations in blood supply to the heart that cause chest pain and result from spasmodic constriction of coronary arteries (Prinzmetal's angina).
• If you have circulatory problems (there may be an exacerbation of symptoms, especially at the start of treatment).
• If your blood volume is reduced (hypovolemia).
• If you have liver function disorder.
• If you are an elderly person.
• If you have high levels of uric acid in the blood (hyperuricemia), as this may increase the risk of gout attacks.
• If you have or have had psoriasis.
• If you have a thyroid problem. Bisoprolol/Hidroclorotiazida Teva may mask symptoms of an overactive thyroid.
• If you have a tumor of the adrenal gland (pheochromocytoma) and are being treated.
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The use of hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Bisoprolol/Hidroclorotiazida Teva.

If you have asthma or other chronic obstructive pulmonary diseases that may cause symptoms, your doctor may need to increase your dose of bronchodilators (beta-sympathomimetics) during treatment with Bisoprolol/Hidroclorotiazida Teva.

As with other beta-blockers, bisoprolol may increase both sensitivity to allergens and the severity of allergic reactions (anaphylactic reactions). This also applies to desensitization therapy. Treatment with adrenaline may not always produce the expected therapeutic effect.

If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Bisoprolol/Hidroclorotiazida Teva, seek medical attention immediately.

If you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur within a few hours to weeks after taking Bisoprolol/Hidroclorotiazida Teva. If left untreated, this may lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing it.

Do not stop taking beta-blockers abruptly unless it is urgently necessary.

If you are to receive general anesthesia, inform the anesthesiologist about your treatment with beta-blockers. Currently, it is recommended to continue treatment, as it may influence heart rhythm and circulatory disorders that may occur during the operation. If it is considered necessary to discontinue beta-blocker treatment before the procedure, it should be done gradually and completed 48 hours before anesthesia.

This medication may cause skin reactions to the sun such as rash, redness of the skin, itching (this is called photosensitivity). If this occurs, protect your skin from sun exposure (with sunblock creams, clothing, avoiding the sun). In cases of severe photosensitivity, it may be necessary to discontinue treatment with Bisoprolol/Hidroclorotiazida Teva, but consult your doctor first.

Note

During treatment with bisoprolol/hydrochlorothiazide, your serum electrolytes (particularly potassium, sodium, and calcium), creatinine, and urea, blood lipids (cholesterol and triglycerides), uric acid, and blood glucose should be regularly monitored to detect alterations in the electrolyte balance, especially hypokalemia, hypochloremic alkalosis, and hypopotasemia.

A metabolic alkalosis may worsen due to an alteration in the balance of fluids and electrolytes.

Cases of acute inflammation of the gallbladder (cholecystitis) have been reported in patients with gallstones.

If you wear contact lenses, you should know that bisoprolol may reduce tear production.

Effects in case of misuse for doping

Competitive athletes should be aware that this medication contains a substance that may produce a positive reaction in doping tests.

Children and adolescents

Bisoprolol/Hidroclorotiazida is not recommended for children.

Other medications and Bisoprolol/Hidroclorotiazida Teva

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

Concomitant use of the following medications with bisoprolol/hydrochlorothiazide is not recommended:

• Calcium antagonists such as verapamil or diltiazem, used to treat certain heart diseases: may cause heart rhythm and heart muscle weakness.
• Central-acting antihypertensive agents (such as clonidine, alpha-methyldopa, moxonidine, reserpine): may cause additional reduction in heart rate and cardiac output, as well as vasodilation. Abrupt withdrawal may cause excessive increase in blood pressure.Central-acting antihypertensive agents can only be withdrawn when treatment with this medication has been interrupted previously for several days.
• Lithium, used to treat depression: reduced lithium elimination may result in more severe damage to the nervous and cardiovascular systems.

Caution should be exercised when using the following medications concomitantly with bisoprolol/hydrochlorothiazide:

• Calcium antagonists such as nifedipine and amlodipine (dihydropyridines), used to treat certain heart diseases: may cause excessive decrease in blood pressure, especially at the start of treatment. In patients with latent heart failure, concomitant treatment with beta-blockers may lead to the manifestation of heart failure.
• ACE inhibitors such as captopril and enalapril, as well as angiotensin II antagonists, used to treat high blood pressure and other heart diseases: may cause excessive decrease in blood pressure and/or acute renal insufficiency at the start of treatment with ACE inhibitors.
• Antiarrhythmic agents such as disopyramide, quinidine, amiodarone, and sotalol, used to treat heart rhythm disorders: the effects of bisoprolol/hydrochlorothiazide and antiarrhythmic agents on heart function may be additive. Potentially fatal heart rhythm disorders (torsades de pointes) may develop.
• Astemizol (an antihistamine), intravenous erythromycin (an antibiotic), halofantrine (used to treat malaria), pentamidine (used to treat parasitic infections), esparfloxacine (an antibiotic), terfenadine (an antihistamine), vincamine (used to treat certain brain diseases): may cause severe heart rhythm disorders.
• Parasympathomimetic agents including tacrine, used to treat Alzheimer's disease: risk of slow heart rate (bradycardia).
• Other beta-blockers, including those contained in eye drops for glaucoma treatment, used to treat heart diseases or eye diseases, have an additive effect.

• Insulin or other medications that lower blood glucose (sulfonilureas), used to treat diabetes: may increase the effect of these medications. Symptoms of low blood glucose (hypoglycemia), especially rapid pulse (tachycardia), may be masked or less pronounced.
• Anesthetics: inform your anesthesiologist that you are taking bisoprolol/hydrochlorothiazide, as beta-blockers may interact with other medications and influence how your body reacts to this situation. If possible, it is recommended to continue treatment with beta-blockers before, during, and after surgery.
• Medications such as digitals, used to treat heart diseases such as congestive heart failure: any potassium or magnesium deficiency may increase the likelihood of digitalis side effects.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, used to relieve pain: may reduce the blood pressure-lowering effect of bisoprolol/hydrochlorothiazide. High doses of NSAIDs may increase the risk of central nervous system side effects.
• NSAIDs such as ibuprofen, used to relieve pain: in patients with reduced blood volume (hypovolemia), may cause acute renal insufficiency.
• Ergotamine derivatives such as bromocriptine, used to treat diseases such as Parkinson's disease: may exacerbate any existing circulatory problems.
• Medications called beta-sympathomimetics, which may be used to treat asthma or chronic obstructive pulmonary diseases: may weaken the effects of both treatments.

• Adrenaline may be needed in higher doses to treat allergic reactions.
• Sympathomimetics that activate both beta and alpha-adrenergic receptors (e.g. adrenaline, noradrenaline): combination with bisoprolol may cause increased blood pressure and exacerbate intermittent claudication.
• Tricyclic antidepressants such as amitriptyline, barbiturates such as phenobarbital, phenothiazines such as chlorpromazine, used to treat diseases such as depression: may cause excessive decrease or increase in blood pressure.
• The effect of medications that reduce uric acid levels may be weakened if bisoprolol/hydrochlorothiazide is taken at the same time.
• Glucocorticoids such as hydrocortisone or dexamethasone (used to treat inflammation), ACTH (used to treat multiple sclerosis or rheumatoid arthritis), carbenoxolone (used to treat ulcers), amphotericin B (an antibiotic), furosemide (a diuretic), or laxatives: may increase potassium loss.
• Cytostatics (e.g. cyclophosphamide, fluorouracil, methotrexate), used to treat cancer: may be expected to increase toxicity in the bone marrow.
• Cholestyramine, colestipol, used to treat high cholesterol: these medications reduce the extent to which the body absorbs hydrochlorothiazide.
• Methyldopa, used to treat high blood pressure: in isolated cases, hemolysis (increase in hemoglobin in the blood separated from red blood cells) has been reported as a result of the formation of antibodies to hydrochlorothiazide.
• Mefloquine, used to treat malaria: may increase the risk of slow heart rate.
• MAO inhibitors such as moclobemide or phenelzine, except for MAO-B inhibitors such as selegiline, used to treat diseases such as depression: may cause excessive decrease or increase in blood pressure.

Bisoprolol/Hidroclorotiazida Teva with food and drinks

During treatment with Bisoprolol/Hidroclorotiazida Teva, make sure to drink enough fluids and eat foods rich in potassium (e.g. bananas, vegetables, nuts) to compensate for potassium loss.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Inform your doctor if you are pregnant or if you think you may be pregnant. Normally, your doctor will advise you to take another medication instead of Bisoprolol/Hidroclorotiazida Teva, as bisoprolol/hydrochlorothiazide is not recommended during pregnancy. This is because bisoprolol/hydrochlorothiazide crosses the placenta and its use after the third trimester of pregnancy may cause potentially harmful effects on the fetus and newborn.

Lactation

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Bisoprolol/hydrochlorothiazide is not recommended for mothers who are breastfeeding.

Fertility

No data are available on the use of the combined preparation and its effect on human fertility. Bisoprolol and hydrochlorothiazide did not show any effects on fertility in animal studies.

Driving and operating machinery

Although Bisoprolol/Hidroclorotiazida Teva usually does not affect your ability to drive or operate machinery, you should be careful when performing these activities, especially at the start of treatment, if you change your medication, or if you consume alcohol. Sometimes, this medication may cause dizziness. Individual reactions to the medication may impair your ability to drive or operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

For oral use.

An individual dose adjustment with the substances separately (i.e., bisoprolol and hydrochlorothiazide) is recommended.

A direct change from monotherapy to combination at fixed doses may be possible if the doctor considers it justified.

The recommended dose is one tablet of 5 mg/12.5 mg or half of 10 mg/25 mg once a day. Your doctor may decide to increase the dose to two tablets of 5 mg/12.5 mg or one of 10 mg/25 mg once a day depending on your response to treatment.

Patients with kidney disease, elderly patients

In case of renal function deterioration, the elimination of the hydrochlorothiazide component of bisoprolol/hydrochlorothiazide is reduced. Your doctor will decide on the most appropriate dose for you.

Administration form

Take this medication as possible in the morning with breakfast, and swallow the tablet whole, without chewing, with some liquid.

The tablet can be divided into equal doses.

Duration of administration

Your doctor will indicate the duration of your treatment.

Use in children and adolescents

Bisoprolol/Hydrochlorothiazide Teva is not recommended in children, as there is no clinical experience.

If you take more Bisoprolol/Hidroclorotiazida Teva than you should

Seek medical attention. He/she may decide on the necessary measures, depending on the degree of overdose. In case of overdose, you must interrupt treatment with Bisoprolol/Hydrochlorothiazide Teva.

The most common signs of bisoprolol/hydrochlorothiazide overdose are a slow heart rate (bradycardia), difficulty breathing (bronchospasm), severe blood pressure drop, acute heart failure, and low blood sugar (hypoglycemia). Other signs of acute or chronic hydrochlorothiazide overdose may be dizziness, nausea, drowsiness, decreased blood volume (hypovolemia), and hypotension.

In case of overdose, treatment with this medication should be interrupted by consulting your doctor.

In case of overdose or accidental ingestion,consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Bisoprolol/Hidroclorotiazida Teva tablets

Do not take a double dose to compensate for the missed doses.

Continue taking Bisoprolol/Hydrochlorothiazide Teva according to the instructions given in this leaflet or as prescribed by your doctor.

If you interrupt treatment with Bisoprolol/Hidroclorotiazida Teva

Do not interrupt or stop your treatment with Bisoprolol/Hydrochlorothiazide Teva without consulting your doctor first.

You should not stop your treatment with this medication abruptly, as it may worsen your heart failure.

Your treatment should be interrupted gradually (reducing the dose by half over a period of 7-10 days), as abrupt interruption of treatment may lead to acute deterioration of the disease.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may have adverse effects, although not all people will experience them.

If you experience the following effects, do not take Bisoprolol/Hidroclorotiazida Teva and visit your doctor or go to the nearest hospital immediately.

• Difficulty breathing and swelling of the legs, which is a symptom of worsening heart failure (may affect up to 1 in 100 people),
• Respiratory problems and wheezing (bronchospasm), especially if you have asthma or chronic bronchitis (may affect up to 1 in 100 people),
• Severe stomach and back pain with a feeling of discomfort that may be symptoms of a condition called pancreatitis (may affect up to 1 in 100 people),
• Symptoms such as the flu and fever that may be signs of a decrease in white blood cells (leucopenia) (may affect up to 1 in 1,000 people) or low granulocyte count in the blood (agranulocytosis) (may affect up to 1 in 10,000 people),
• Easy bruising and nosebleeds that may be symptoms of low platelet count (thrombocytopenia) (may affect up to 1 in 1,000 people),
• Abdominal pain, loss of appetite, yellowing of the whites of the eyes and skin, dark urine that may be caused by liver inflammation (hepatitis) (may affect up to 1 in 1,000 people),
• Yellowing of the skin and eyes (jaundice) (may affect up to 1 in 1,000 people),
• Allergic reactions; itching, redness, skin rash, light-sensitive skin rash (photodermatitis), skin bleeding (purpura), urticaria; severe allergic reactions, which may include swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing (may affect up to 1 in 1,000 people),
• Chest pain (may affect up to 1 in 10,000 people),
• Poriasis (a condition in which scaly plates develop on the skin) or skin eruptions such as psoriasis, worsening of existing psoriasis (may affect up to 1 in 10,000 people),
• Skin diseases with red scaly patches on the nose and cheeks (lupus erythematosus) (may affect up to 1 in 10,000 people),
• Acute respiratory distress (signs include severe difficulty breathing, fever, weakness, and confusion) (very rare, may affect up to 1 in 10,000 people).

Other possible adverse effects

Frequent (may affect up to 1 in 10 people)

• Some adverse effects may only be seen in a blood test, such as elevated levels of fats in the blood (triglycerides, cholesterol), elevated blood glucose (hyperglycemia), and elevated serum uric acid levels (hyperuricemia, which may be associated with gout),
• Glucose excretion in the urine (glucosuria),
• Disorders in fluid and electrolyte balance, especially reduced serum potassium levels (hypokalemia, which may cause fatigue, exhaustion, muscle weakness, abnormal sensations in the extremities (paresthesias), paralysis, apathy, muscle weakness with constipation, excessive gas accumulation in the gastrointestinal tract (flatulence), or alterations in heart rhythm, intestinal obstruction, alterations in consciousness, and coma,
• Reduced serum sodium levels (hyponatremia, which may cause fatigue and confusion, muscle cramps, seizures, or coma), reduced serum magnesium levels (hypomagnesemia, which may be associated with muscle problems), reduced serum chloride levels (hypochloremia),
• Elevated serum calcium levels (hypercalcemia, causing abdominal pain, nausea, and vomiting, constipation, loss of appetite, excessive thirst, excessive urination, fatigue, weakness, and weight loss),
• Increased acids in the blood (metabolic acidosis, which may be associated with fatigue, nausea, vomiting, rapid breathing),
• Fatigue*,
• Dizziness*,
• Headache*,
• Sensation of coldness or numbness in the extremities,
• Nausea, vomiting, diarrhea, constipation.

Rare (may affect up to 1 in 100 people)

• Exhaustion,
• Sleep disorders,
• Depression,
• Slow heart rate (bradycardia),
• Heart rhythm disorders (called AV conduction disorders),
• Low blood pressure, which may be associated with changes in posture and may be characterized by feelings of dizziness and weakness when standing up after sitting (orthostatic hypotension),
• Loss of appetite,
• Abdominal pain,
• Some adverse effects may only be seen in a blood test: increase of certain molecules in the blood (amylases, creatinine, and urea),
• Muscle weakness and cramps.

Rare (may affect up to 1 in 1,000 people)

• Nightmares, hallucinations,
• Reduced tear flow (note if you wear contact lenses),
• Visual disorders,
• Auditory disorders,
• Circulatory collapse (syncope),
• Allergic rhinitis (nasal discharge),
• Some adverse effects may only be seen in a blood test: increase of certain liver enzymes in the blood (AST, ALT),
• Erectile dysfunction.

Very rare (may affect up to 1 in 10,000 people)

• Some adverse effects may only be seen in a blood test, such as metabolic alkalosis,
• Conjunctivitis (inflammation of the membrane around the eye),
• Hair loss.

Frequency not known (cannot be estimated from available data)

• Cancer of the skin and lips (non-melanoma skin cancer),
• Loss of vision or eye pain due to increased pressure (possible signs of accumulation of fluid in the vascular layer of the eye (choroidal hemorrhage or acute angle-closure glaucoma),
• Pulmonary interstitial disease.

*These signs and symptoms appear especially at the beginning of treatment. They are usually mild and usually disappear within one or two weeks.

Reporting adverse effects

If you experience any type of adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and blister after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.Store in the original packaging.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Bisoprolol/Hidroclorotiazida Teva Composition

• The active ingredients are bisoprolol hemifumarate and hidroclorotiazida.
• Each tablet contains 10 mg of bisoprolol hemifumarate and 25 mg of hidroclorotiazida.
• The other components are:
• Core: cornstarch (gluten-free), microcrystalline cellulose, anhydrous colloidal silica, anhydrous calcium hydrogen phosphate, magnesium stearate.
• Coating: hypromellose, polisorbate 80, macrogol 400, brilliant blue FCF E133 aluminum lake, quinoline yellow E104 aluminum lake, and titanium dioxide E171.

Appearance of Bisoprolol/Hidroclorotiazida Teva and packaging contents

Your tablets are blue, film-coated, round, scored on one side, and engraved with a “B” on the left side of the score and an “H” on the right side of the score. The other side is engraved with a “10”. They are available in blister packs containing 28, 30, 50, 56, and 100 tablets.

Only some packaging sizes may be marketed.

Marketing Authorization Holder and responsible manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13

H-4042 Debrecen

Hungary

or

Pharmachemie B.V.

Swensweg 5, Postbus 552,

2003 RN Haarlem

Netherlands

or

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31-546 Cracovia

Poland

This medicine is registered in the Member States of the European Economic Area with the following names:

BE:Co-Bisoprolol TEVA 10 mg / 25 mg filmomhulde tabletten

DE:Bisoprolol-TEVA® comp. 10 mg / 25 mg Filmtabletten

ES:Bisoprolol/HCTZ TEVA 10/25mg comprimidos recubiertos con película EFG

Last review date of this leaflet:April 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http: //www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/69667/P_69667.html

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